FDA Inspection 720855 — Oregon Fertility Institute, LLC
The FDA completed an inspection of Oregon Fertility Institute, LLC on Apr 27, 2011 in Portland, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 27, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Portland, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12385 | 21 CFR 1271.150(c)(2) | Responsibility for review before distribution |